NCT06312631 Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults
| NCT ID | NCT06312631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-03-26 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
On a functional level, performing the actions of daily life requires coordinated activity of the muscles of the upper limbs. The quality of motor recovery and/or technical assistance aimed at compensating for the movement deficit of the paretic upper limb (MSP) determines the possibilities of using the upper limb (MS) in activities of daily life. Interventions in the chronic phase of stroke aim to return home. The integration of the paretic upper limb into daily life activities is a major issue regarding the prognosis of recovery of use of the upper limb. Independence in daily life becomes an ultimate goal to take charge of. This study focuses on a new technical aid device, standard orthosis type, expanding the range of gripping gloves: the SaeboGlove in everyday environments. These MS orthoses help improve the use and function of the MSP in post-stroke adults as well as their independence and participation in society.
Eligibility Criteria
Inclusion Criteria: * Patient suffering from a motor deficit of the upper limb resulting from an ischemic or hemorrhagic stroke, hemispheric or brainstem, confirmed by brain imaging ; * Patient who suffered a stroke more than three months ago; * Patient unable to actively extend long fingers (hand opening) to voluntarily grasp an empty glass (upper and lower diameter of 7 and 6 cm respectively, height of 12 to 15 cm, weight of 125g, identical to equipment used for ARAT), with a palmar grip (cylindrical grip), while the subject can hold the previously placed glass passively in the hand; * Patient capable of passively opening the hand sufficient to grasp the glass when the gripping glove is put on, with the possibility of actively closing the hand; * Patient with the ability to put on and remove the SaeboGlove® gripping glove with the help of a third person if necessary and/or available. * Patient with a smartphone, tablet and/or computer compatible with video taking and teleconsultation. * Free, informed and signed consent by the participant and/or the person having guardianship and the investigator (at the latest on the day of inclusion and before any examination required by the research); * Person affiliated to or beneficiary of a social security system. Exclusion Criteria: * Patient presenting retraction or stiffness of the fingers and wrist preventing complete extension of the long fingers and thumb, the wrist being at 15° extension; * Patient with moderate or severe muscular spasticity of the wrist flexors and the long and short flexors of the fingers and thumb (Modified Ashworth Scale ≥ 3); * Patient with limited active elbow extension, not allowing the ipsilateral knee to be reached with the hand, the subject being seated with the trunk vertical (approach limitation); * Patient with an active anterior shoulder elevation range of less than 15°; * Patient with other upper limb deficiencies likely to influence participation; * Patient and/or entourage who do not have access to teleconsultation, and/or can be reached remotely; * Patient with severe aphasia, Boston Diagnostic Aphasia Examination (BDAE) ≤ 3; * Presence of moderate or severe edema localized to the wrist and hand; * Patient allergic to Latex * History of upper limb surgery less than 6 months old. * Pregnant and/or breastfeeding women * Patient deprived of liberty (detained/incarcerated); * Patient under judicial protection * Impossibility of giving the person informed information and ensuring the subject's compliance due to impaired physical and/or psychological health
Contact & Investigator
Claire VILLEPINTE
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT06312631 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06312631 currently recruiting?
Yes, NCT06312631 is actively recruiting participants. Contact the research team at villepinte.c@chu-toulouse.fr for enrollment information.
Where is the NCT06312631 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT06312631 clinical trial?
NCT06312631 is sponsored by University Hospital, Toulouse. The principal investigator is Claire VILLEPINTE at University Hospital, Toulouse. The trial plans to enroll 100 participants.
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